Kyrgyzstan Medical Device Nomenclature: GMDN Codes, Types and the National Register

1. Key takeaways

Kyrgyzstan uses the Global Medical Device Nomenclature (GMDN) to identify device types and assigns a registration number after registration, under which the device is entered into the national register of registered medical devices. Article 2 of Annex 1 to Cabinet of Ministers Resolution No. 513 simultaneously defines three hierarchical concepts: medical device type, model and nomenclature. The type (the GMDN code) determines what the product is, the model determines which specific variants exist within that family, and the nomenclature is the systematized classification list maintained at the national level. Together, the three concepts determine how many models a single registration dossier can contain. Misjudging the type-model structure is one of the most expensive planning errors a manufacturer can make, because it directly controls the number of dossiers, the fees and the total time to market.

2. Legal basis

1. Resolution No. 513 of the Cabinet of Ministers, dated August 27, 2024, Annex 1, Article 2:
   • Global Medical Device Nomenclature (GMDN): a systematized nomenclature classification code used to identify medical devices;
   • Medical device type: a set of medical devices with the same or similar purpose and/or construction;
   • Model: a variety of medical device developed on the basis of the parent product, sharing common structural features with it, intended for improved, extended or specialized applications;
   • Nomenclature: a systematized nomenclature list containing type names, unique codes and type descriptions, including classification features by purpose and/or construction;
   • Registration number: the identifier assigned to a device upon registration, under which it is entered into the national register of registered medical devices of the Kyrgyz Republic.
2. Annex 1 to Resolution No. 513, Article 1: the procedures cover the maintenance of the nomenclature and the national register.
3. Law No. 216, Article 29: devices that have been registered and entered into the national register are imported on the basis of the register entry.

3. Expert insights

Insight 1: The GMDN code is an identity, not a formality.

Writing GMDN into the statutory definitions means it is the legal method of identifying the device. The practical consequence: choosing the wrong GMDN code places the product in the wrong type group, which in turn distorts the classification rationale, the testing plan and the review pathway. We recommend determining the GMDN code before drafting the classification rationale, rather than filling it in casually at the end of dossier preparation. A code chosen early anchors every downstream document; a code changed late forces revisions across the technical file, the application form and the labeling.

Insight 2: The two-level type-model structure determines the capacity of a dossier.

A type is a group of devices with the same or similar purpose and/or construction; a model is a variant developed from the parent product. One registration dossier normally corresponds to one type and contains multiple models. This means the decision to split a product line into several dossiers or to consolidate it into one depends on whether the products fall within the same GMDN type. Splitting wrongly or merging wrongly leads to additional time and cost. Mapping the entire product portfolio against GMDN types before filing is therefore a portfolio-level planning exercise, not a per-product clerical task.

Insight 3: Model changes require a new application, which makes forward planning a hard requirement.

A multilateral country survey explicitly records that when a device model is changed or improved, a re-registration application must be submitted, and components not included at initial registration must be registered separately. Combined with the type-model structure, the conclusion is direct: at first registration, all models and specifications expected to be launched within the next three years should be included in the same dossier, so that the cost of repeated registrations is absorbed once (see article 20 of this series). Treating the first registration as a portfolio event rather than a single-product event is the most effective way to control long-term regulatory spend in Kyrgyzstan.

Insight 4: The national register is the passport at the import stage.

Article 29 of Law No. 216 makes registration and entry into the national register the precondition for import on the basis of the register record. Registration and listing are two separate actions: after the certificate is issued, the data are entered into the register, and import clearance relies on the register entry. Companies should verify, immediately after receiving the certificate, that the register record matches the certificate content. If the model range recorded in the register is narrower than the range on the certificate, imports will still be blocked. Checking the register entry is a five-minute task that prevents a shipment-level crisis.

Insight 5: The nomenclature is maintained dynamically.

Article 1 of Annex 1 to Resolution No. 513 lists maintenance of the nomenclature as part of the procedures, which means the national nomenclature list will be updated over time. Companies running multi-product, multi-year programs should periodically re-check whether the GMDN codes they have used have changed and avoid letting new products inherit outdated codes. A simple internal ledger of codes, determination dates and determination rationale turns this from an ad hoc worry into a routine annual review item.

4. Practical recommendations

First, fix the GMDN code before the classification rationale. We recommend reversing the usual order: determine the GMDN code and type membership first, then build the risk class rationale under Decision No. 173. The two threads then corroborate each other and the classification conclusion is more robust under review.

Second, organize the product line by type and cover several years of models in one filing. At first registration, include in the same dossier all models of the same type expected within the next three years, and explain in the dossier the structural relationship of each model to the parent product and the differences between them.

Third, check the national register record immediately after certification. We recommend verifying five items: device name; type and model list; registration number; certificate holder; and authorized representative. Where the register record and the certificate diverge, apply for correction promptly, before the first import shipment is scheduled.

Fourth, maintain a GMDN code ledger with an annual review. Record the code, the determination date and the determination rationale for each product line, review the ledger annually, and track updates to the nomenclature list so that new filings never rely on stale codes.

5. Verification checklist

• □ The GMDN code for each product has been determined, with the rationale and date recorded;
• □ The type-model structure is defined: one dossier corresponds to one type containing all models to be registered;
• □ The model list at first registration covers all specifications expected to be launched within three years;
• □ After certification, the five register items were checked: device name, type and model list, registration number, holder, authorized representative;
• □ A GMDN code ledger exists with an annual review mechanism;
• □ Confirmed that import relies on the national register entry (Article 29 of Law No. 216).

Regulatory information verified as of October 29, 2026.

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